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A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)

NCT03729245 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2023-04-11

Study results available
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Summary

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

Conditions

Interventions

BIOLOGICAL

bempegaldesleukin

Specified dose on specified days

DRUG

sunitinib

Specified dose on specified days

BIOLOGICAL

nivolumab

Specified dose on specified days

DRUG

cabozantinib

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Study Director · Nektar Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2022-01-07
Completion
2022-10-19
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • Mexico
  • New Zealand
  • Peru
  • Russia
  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729245 on ClinicalTrials.gov